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Nordic Luveris Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00553293
First Posted: November 5, 2007
Last Update Posted: November 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Regionshospitalet Viborg, Skive
Karolinska University Hospital
Helse Fonna
Turku Hospital
Odense University Hospital
Herlev Hospital
Holbaek Sygehus
Hvidovre University Hospital
Information provided by:
Rigshospitalet, Denmark
  Purpose
To study whether addition of human LH hormone (Luveris) during the final days of stimulation with recombinant FSH (Gonal-f) for controlled ovarian stimulation will be of benefit for patients undergoing in vitro fertilisation.

Condition Intervention Phase
Infertility In Vitro Fertilization Drug: recombinant luteinizing hormone (Luveris) Drug: recombinant follicle stimulating hormone (Gonal-f) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Recombinant LH Supplementation to Recombinant FSH During the Final Days of Controlled Ovarian Stimulation for IVF: a Multicentre, Prospective, Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Ongoing pregnancy rate per started stimulation cycle [ Time Frame: ultrasound showing ongoing pregnancy ]

Secondary Outcome Measures:
  • Ongoing pregnancy in subgroups of patients with lo0w serum LH levels [ Time Frame: ultrasound for ongoing pregnancy in subgroups ]

Enrollment: 526
Study Start Date: August 2003
Study Completion Date: November 2004
Arms Assigned Interventions
Active Comparator: A,1
rFSH + rLH arm
Drug: recombinant luteinizing hormone (Luveris)
75 iu/day form cycle day 6
Other Name: Luveris
Placebo Comparator: A,2
rFSH alone
Drug: recombinant follicle stimulating hormone (Gonal-f)
rFSH 150 iu/day
Other Name: Gonal-f

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age below 40
  • Infertility treatable by IVF or ICSI
  • Regular cycles

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553293


Locations
Denmark
Anders Nyboe Andersen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Regionshospitalet Viborg, Skive
Karolinska University Hospital
Helse Fonna
Turku Hospital
Odense University Hospital
Herlev Hospital
Holbaek Sygehus
Hvidovre University Hospital
Investigators
Principal Investigator: Anders N Andersen, professor Fertility Clinic Rigshospitalet
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00553293     History of Changes
Other Study ID Numbers: KF02-035/03
First Submitted: November 2, 2007
First Posted: November 5, 2007
Last Update Posted: November 5, 2007
Last Verified: November 2007

Keywords provided by Rigshospitalet, Denmark:
infertility
in vitro fertilization
LH supplementation
Benefits

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs